Regular Strength Acid Reducer recalled over manufacturing violations
- Recall date
- October 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Perrigo Company PLC recalls Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-87…
- Recall number
- D-1015-2020
- FDA classification
- Class II
- Brand / firm
- Perrigo Company PLC
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
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